Report date: Apr 16, 2024 Conflict count: 351559 Publisher: Case Journals Title count: 1 Conflict count: 184 ========================================================== Created: 2019-04-09 20:34:25.0 ConfID: 5458597 CauseID: 1442812580 OtherID: 1441051145, 1441906906, 1442812580 JT: Case Medical Research MD: Case,null,null,null,2019,Rheumatology I: Rheumatoid Arthritis DOI: 10.31525/cmr-d62285(Journal) (5458597-N ) DOI: 10.31525/cmr-fbd68c(Journal) ========================================================== Created: 2019-05-03 21:32:14.0 ConfID: 5466662 CauseID: 1444541238 OtherID: 1444541238 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Lynparza,olaparib DOI: 10.31525/cmr-c84f02(Journal) (5466662-N ) DOI: 10.31525/cmr-112db43(Journal) ========================================================== Created: 2019-05-03 21:35:59.0 ConfID: 5466936 CauseID: 1444542038 OtherID: 1444542038 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Eflornithine, Treatment of familial adenomatous polyposis DOI: 10.31525/cmr-116dee0(Journal) (5466936-N ) DOI: 10.31525/cmr-116def0(Journal) ========================================================== Created: 2019-05-03 18:06:59.0 ConfID: 5468226 CauseID: 1444527727 OtherID: 1442079816 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Repaglinide Accord, repaglinide, Diabetes Mellitus, Type 2, Date of authorisation: 22/12/2011, Revision: 5, Status: Authorised DOI: 10.31525/cmr-ebb00c(Journal) (5468226-N ) DOI: 10.31525/cmr-3996c9(Journal) ========================================================== Created: 2019-09-21 05:52:28.0 ConfID: 5468612 CauseID: 1454618187 OtherID: 1454618187 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Dupixent,dupilumab DOI: 10.31525/cmr-c84efd(Journal) (5468612-N ) DOI: 10.31525/cmr-1d3ecb5(Journal) ========================================================== Created: 2019-05-03 18:27:29.0 ConfID: 5468738 CauseID: 1444529257 OtherID: 1442079816 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Methylthioninium, treatment of frontotemporal dementia with parkinsonism-17 DOI: 10.31525/cmr-ebb010(Journal) (5468738-N ) DOI: 10.31525/cmr-eb27fd(Journal) ========================================================== Created: 2019-05-03 18:27:44.0 ConfID: 5468740 CauseID: 1444529267 OtherID: 1442079816 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Methylthioninium, treatment of progressive non-fluent aphasia DOI: 10.31525/cmr-ebb00a(Journal) (5468740-N ) DOI: 10.31525/cmr-eb27ff(Journal) ========================================================== Created: 2019-05-03 18:27:44.0 ConfID: 5468741 CauseID: 1444529267 OtherID: 1442079816 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Methylthioninium, Treatment of progressive supranuclear palsy DOI: 10.31525/cmr-ebb014(Journal) (5468741-N ) DOI: 10.31525/cmr-eb2801(Journal) ========================================================== Created: 2019-05-03 18:27:44.0 ConfID: 5468742 CauseID: 1444529267 OtherID: 1442135350 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Mozobil,plerixafor DOI: 10.31525/cmr-ed3b4e(Journal) (5468742-N ) DOI: 10.31525/cmr-eceeab(Journal) ========================================================== Created: 2019-05-03 18:27:44.0 ConfID: 5468743 CauseID: 1444529267 OtherID: 1442135350 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Imnovid (previously Pomalidomide Celgene),pomalidomide DOI: 10.31525/cmr-ed3b4b(Journal) (5468743-N ) DOI: 10.31525/cmr-eceeac(Journal) ========================================================== Created: 2019-05-03 20:23:14.0 ConfID: 5468753 CauseID: 1444536342 OtherID: 1444529419, 1444529465, 1444529486, 1444529502, 1444529732, 1444530915, 1444531559, 1444532554, 1444532577, 1444532687, 1444532998, 1444533000, 1444533135, 1444534681, 1444535021, 1444535087, 1444536342 JT: Case Medical Research MD: Case Medical Research,null,null,null,2000,[Trial of device that is not approved or cleared by the U.S. FDA] DOI: 10.31525/ct1-nct03897751(Journal) (5468753-N ) DOI: 10.31525/ct1-nct03839199(Journal) ========================================================== Created: 2019-05-09 09:01:47.0 ConfID: 5477217 CauseID: 1445305826 OtherID: 1444529267 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Sprycel, dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma,Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Date of authorisation: 20/11/2006, Revision: 32, Status: Authorised DOI: 10.31525/cmr-ed3b4f(Journal) (5477217-N ) DOI: 10.31525/cmr-eceead(Journal) ========================================================== Created: 2019-10-13 15:08:06.0 ConfID: 5536998 CauseID: 1456117660 OtherID: 1456117620 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,The Impact of Electroacupuncture on Clinical Effect,Brain Structural and Functional Changes on Spinal Cord Injury DOI: 10.31525/ct1-nct03909958(Journal) (5536998-N ) DOI: 10.31525/ct1-nct03909087(Journal) ========================================================== Created: 2019-10-13 15:39:21.0 ConfID: 5537491 CauseID: 1456118748 OtherID: 1456118508 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Gut Microbiota Pilot Study DOI: 10.31525/ct1-nct03897023(Journal) (5537491-N ) DOI: 10.31525/ct1-nct03892590(Journal) ========================================================== Created: 2019-10-13 16:55:51.0 ConfID: 5537888 CauseID: 1456121067 OtherID: 1456119438, 1456119562, 1456121067 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,PoNS Clinical Experience Program (TBI) DOI: 10.31525/ct1-nct03882554(Journal) (5537888-N ) DOI: 10.31525/ct1-nct03852732(Journal) ========================================================== Created: 2019-10-13 17:19:21.0 ConfID: 5538684 CauseID: 1456121761 OtherID: 1456117588 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Wrist Worn Blood Pressure Measurement DOI: 10.31525/ct1-nct03911349(Journal) (5538684-N ) DOI: 10.31525/ct1-nct03919136(Journal) ========================================================== Created: 2019-10-13 17:31:51.0 ConfID: 5538756 CauseID: 1456122092 OtherID: 1456117035 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Summary of opinion: Lynparza,olaparib DOI: 10.31525/cmr-c89d5c(Journal) (5538756-N ) DOI: 10.31525/cmr-11222fa(Journal) ========================================================== Created: 2019-10-13 17:35:06.0 ConfID: 5538778 CauseID: 1456122178 OtherID: 1456122171 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Orphan designation: Eflornithine, Treatment of familial adenomatous polyposis DOI: 10.31525/cmr-1161dcb(Journal) (5538778-N ) DOI: 10.31525/cmr-1161dd5(Journal) ========================================================== Created: 2019-10-13 20:35:51.0 ConfID: 5538783 CauseID: 1456127194 OtherID: 1456118959, 1456127194 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease DOI: 10.31525/ct1-nct03890445(Journal) (5538783-N ) DOI: 10.31525/ct1-nct04022083(Journal) ========================================================== Created: 2019-10-13 17:46:36.0 ConfID: 5538840 CauseID: 1456122477 OtherID: 1456118309 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma DOI: 10.31525/ct1-nct03899740(Journal) (5538840-N ) DOI: 10.31525/ct1-nct03934801(Journal) ========================================================== Created: 2019-10-13 19:09:21.0 ConfID: 5539094 CauseID: 1456124875 OtherID: 1456121775 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,FDA approves pembrolizumab plus axitinib for advanced renal cell carcinoma DOI: 10.31525/fda1-ucm636395.htm(Journal) (5539094-N ) DOI: 10.31525/cmr-14804d4(Journal) ========================================================== Created: 2019-10-13 19:09:21.0 ConfID: 5539095 CauseID: 1456124875 OtherID: 1456117067 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,FDA approves atezolizumab for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer DOI: 10.31525/fda1-ucm633065.htm(Journal) (5539095-N ) DOI: 10.31525/cmr-14804dc(Journal) ========================================================== Created: 2019-10-13 19:09:21.0 ConfID: 5539096 CauseID: 1456124875 OtherID: 1456117374 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,FDA grants accelerated approval to erdafitinib for metastatic urothelial carcinoma DOI: 10.31525/fda1-ucm635910.htm(Journal) (5539096-N ) DOI: 10.31525/cmr-14804d7(Journal) ========================================================== Created: 2019-10-13 19:09:21.0 ConfID: 5539097 CauseID: 1456124875 OtherID: 1456117357 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,FDA expands pembrolizumab indication for first-line treatment of NSCLC (TPS ≥1%) DOI: 10.31525/fda1-ucm635857.htm(Journal) (5539097-N ) DOI: 10.31525/cmr-14804da(Journal) ========================================================== Created: 2019-10-13 19:09:21.0 ConfID: 5539098 CauseID: 1456124875 OtherID: 1456116764 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2018,FDA approves tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm DOI: 10.31525/fda1-ucm629090.htm(Journal) (5539098-N ) DOI: 10.31525/cmr-18ea492(Journal) ========================================================== Created: 2019-10-13 19:09:36.0 ConfID: 5539100 CauseID: 1456124881 OtherID: 1456116924 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices DOI: 10.31525/fda2-ucm631412.htm(Journal) (5539100-N ) DOI: 10.31525/cmr-14804ef(Journal) ========================================================== Created: 2019-10-13 19:12:21.0 ConfID: 5539106 CauseID: 1456124959 OtherID: 1456124067 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients. DOI: 10.31525/ct1-nct03963505(Journal) (5539106-N ) DOI: 10.31525/ct1-nct03978494(Journal) ========================================================== Created: 2019-10-13 19:19:21.0 ConfID: 5539115 CauseID: 1456125205 OtherID: 1456117534 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Study of TQB2450 Combined With Anlotinib in the Treatment of Mutation Positive Lung Cancer DOI: 10.31525/ct1-nct03910270(Journal) (5539115-N ) DOI: 10.31525/ct1-nct03983928(Journal) ========================================================== Created: 2019-10-13 19:43:06.0 ConfID: 5539147 CauseID: 1456125954 OtherID: 1456125919 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Novel Training Environment to Normalize Altered Finger Force Direction Post Stroke DOI: 10.31525/ct1-nct03995069(Journal) (5539147-N ) DOI: 10.31525/ct1-nct03993756(Journal) ========================================================== Created: 2019-10-13 19:43:21.0 ConfID: 5539149 CauseID: 1456125961 OtherID: 1456124533 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors. DOI: 10.31525/ct1-nct03972436(Journal) (5539149-N ) DOI: 10.31525/ct1-nct03993678(Journal) ========================================================== Created: 2019-10-13 20:59:21.0 ConfID: 5539166 CauseID: 1456127743 OtherID: 1456116897, 1456127743 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Summary of opinion: Tecentriq,atezolizumab DOI: 10.31525/cmr-a30d19(Journal) (5539166-N ) DOI: 10.31525/cmr-189d3ad(Journal) ========================================================== Created: 2019-10-13 19:55:51.0 ConfID: 5539168 CauseID: 1456126271 OtherID: 1456116897 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Summary of opinion: Forxiga,dapagliflozin DOI: 10.31525/cmr-a30d14(Journal) (5539168-N ) DOI: 10.31525/cmr-1658a65(Journal) ========================================================== Created: 2019-10-13 23:05:20.0 ConfID: 5539169 CauseID: 1456133829 OtherID: 1456117035, 1456133829 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Summary of opinion: Dupixent,dupilumab DOI: 10.31525/cmr-c89d55(Journal) (5539169-N ) DOI: 10.31525/cmr-1d401b1(Journal) ========================================================== Created: 2019-10-13 20:21:06.0 ConfID: 5539191 CauseID: 1456126870 OtherID: 1456126361 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma DOI: 10.31525/ct1-nct04002947(Journal) (5539191-N ) DOI: 10.31525/ct1-nct04014348(Journal) ========================================================== Created: 2019-10-13 20:37:51.0 ConfID: 5539199 CauseID: 1456127236 OtherID: 1456124917 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy DOI: 10.31525/ct1-nct03978858(Journal) (5539199-N ) DOI: 10.31525/ct1-nct04023526(Journal) ========================================================== Created: 2019-10-13 20:59:36.0 ConfID: 5539262 CauseID: 1456127749 OtherID: 1456116890 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Summary of opinion: Keytruda,pembrolizumab DOI: 10.31525/cmr-a30d0d(Journal) (5539262-N ) DOI: 10.31525/cmr-189d3b1(Journal) ========================================================== Created: 2019-10-13 21:12:06.0 ConfID: 5539327 CauseID: 1456130134 OtherID: 1456120263 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Intravenous Iloprost in Subjects With Symptomatic Raynaud''s Phenomenon Secondary to Systemic Sclerosis DOI: 10.31525/ct1-nct03867097(Journal) (5539327-N ) DOI: 10.31525/ct1-nct04040322(Journal) ========================================================== Created: 2019-10-13 21:28:36.0 ConfID: 5539468 CauseID: 1456130529 OtherID: 1456125341 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Orphan designation: Diacerein, Treatment of epidermolysis bullosa DOI: 10.31525/cmr-152a1a1(Journal) (5539468-N ) DOI: 10.31525/cmr-19c815d(Journal) ========================================================== Created: 2019-10-13 22:47:51.0 ConfID: 5540525 CauseID: 1456133101 OtherID: 1456122564 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,GEN1042 Safety Trial in Subjects With Malignant Solid Tumors DOI: 10.31525/ct1-nct03937024(Journal) (5540525-N ) DOI: 10.31525/ct1-nct04083599(Journal) ========================================================== Created: 2019-10-13 23:05:20.0 ConfID: 5540778 CauseID: 1456133829 OtherID: 1456127743 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Summary of opinion: Lucentis,ranibizumab DOI: 10.31525/cmr-189d3a0(Journal) (5540778-N ) DOI: 10.31525/cmr-1d401ab(Journal) ========================================================== Created: 2019-10-13 23:13:35.0 ConfID: 5540884 CauseID: 1456134083 OtherID: 1456133969 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Phase I Clinical Trial of One Vaccine DOI: 10.31525/ct1-nct04099303(Journal) (5540884-N ) DOI: 10.31525/ct1-nct04100772(Journal) ========================================================== Created: 2019-10-13 23:59:35.0 ConfID: 5541311 CauseID: 1456135839 OtherID: 1456121839 JT: Case Medical Research MD: Kernel Networks Inc.,null,null,null,2019,Orphan designation: DOI: 10.31525/cmr-10e7699(Journal) (5541311-N ) DOI: 10.31525/cmr-1efde81(Journal) ========================================================== Created: 2019-10-29 15:21:01.0 ConfID: 5553188 CauseID: 1457225193 OtherID: 1457224014 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Leukemia, Myeloid,Leukemia, Lymphoid, Date of authorisation: 01/07/2013, Revision: 20, Status: Authorised DOI: 10.31525/cmr-2071be8(Journal) (5553188-N ) DOI: 10.31525/cmr-207280d(Journal) ========================================================== Created: 2019-11-06 07:22:49.0 ConfID: 5555916 CauseID: 1457743628 OtherID: 1457700130 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations DOI: 10.31525/cmr-2106c4c(Journal) (5555916-N ) DOI: 10.31525/cmr-21156ed(Journal) ========================================================== Created: 2019-11-06 07:22:49.0 ConfID: 5555917 CauseID: 1457743628 OtherID: 1457340905 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Udenyca, pegfilgrastim, Neutropenia, Date of authorisation: 21/09/2018, Revision: 1, Status: Authorised DOI: 10.31525/cmr-208eb13(Journal) (5555917-N ) DOI: 10.31525/cmr-21156ec(Journal) ========================================================== Created: 2019-11-06 07:31:46.0 ConfID: 5555918 CauseID: 1457743974 OtherID: 1457340945 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Eucreas, vildagliptin / metformin, Diabetes Mellitus, Type 2, Date of authorisation: 14/11/2007, Revision: 18, Status: Authorised DOI: 10.31525/cmr-208eb19(Journal) (5555918-N ) DOI: 10.31525/cmr-21156f0(Journal) ========================================================== Created: 2019-11-06 08:22:46.0 ConfID: 5555944 CauseID: 1457745440 OtherID: 1457341081 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Graft Rejection, Date of authorisation: 14/02/1996, Revision: 31, Status: Authorised DOI: 10.31525/cmr-208eb29(Journal) (5555944-N ) DOI: 10.31525/cmr-2115709(Journal) ========================================================== Created: 2019-11-06 08:25:46.0 ConfID: 5555945 CauseID: 1457745527 OtherID: 1457341081 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Truberzi, eluxadoline, Irritable Bowel Syndrome,Diarrhea, Date of authorisation: 19/09/2016, Revision: 5, Status: Authorised DOI: 10.31525/cmr-208eb2c(Journal) (5555945-N ) DOI: 10.31525/cmr-211570b(Journal) ========================================================== Created: 2019-11-06 08:25:46.0 ConfID: 5555946 CauseID: 1457745527 OtherID: 1457340905 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Atriance, nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Date of authorisation: 22/08/2007, Revision: 20, Status: Authorised DOI: 10.31525/cmr-208eb08(Journal) (5555946-N ) DOI: 10.31525/cmr-211570d(Journal) ========================================================== Created: 2019-11-06 08:31:46.0 ConfID: 5555947 CauseID: 1457745689 OtherID: 1457340945 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Sildenafil Teva, sildenafil, Erectile Dysfunction, Date of authorisation: 30/11/2009, Revision: 14, Status: Authorised DOI: 10.31525/cmr-208eb14(Journal) (5555947-N ) DOI: 10.31525/cmr-2115715(Journal) ========================================================== Created: 2019-11-06 08:31:46.0 ConfID: 5555948 CauseID: 1457745689 OtherID: 1457340905 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Erelzi, etanercept, Arthritis, Psoriatic,Psoriasis,Arthritis, Juvenile Rheumatoid,Arthritis, Rheumatoid,Spondylitis, Ankylosing, Date of authorisation: 23/06/2017, Revision: 4, Status: Authorised DOI: 10.31525/cmr-208eb0e(Journal) (5555948-N ) DOI: 10.31525/cmr-2115716(Journal) ========================================================== Created: 2019-11-06 08:34:46.0 ConfID: 5555949 CauseID: 1457745726 OtherID: 1457719417 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Axura, memantine, Alzheimer Disease, Date of authorisation: 17/05/2002, Revision: 25, Status: Authorised DOI: 10.31525/cmr-210d408(Journal) (5555949-N ) DOI: 10.31525/cmr-2115718(Journal) ========================================================== Created: 2019-11-06 08:34:46.0 ConfID: 5555950 CauseID: 1457745726 OtherID: 1457719417 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Memantine Merz, memantine hydrochloride, Alzheimer Disease, Date of authorisation: 22/11/2012, Revision: 6, Status: Authorised DOI: 10.31525/cmr-210d406(Journal) (5555950-N ) DOI: 10.31525/cmr-211571a(Journal) ========================================================== Created: 2019-11-06 08:34:46.0 ConfID: 5555951 CauseID: 1457745726 OtherID: 1457340686 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Temodal, temozolomide, Glioma,Glioblastoma, Date of authorisation: 26/01/1999, Revision: 32, Status: Authorised DOI: 10.31525/cmr-208eb01(Journal) (5555951-N ) DOI: 10.31525/cmr-211571b(Journal) ========================================================== Created: 2019-11-07 01:02:53.0 ConfID: 5556111 CauseID: 1457783901 OtherID: 1457749076 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA Office of Hematology Oncology Products Reorganizes, Renamed Office of Oncologic Diseases DOI: 10.31525/cmr-2118045(Journal) (5556111-N ) DOI: 10.31525/cmr-21180c0(Journal) ========================================================== Created: 2019-11-08 07:47:25.0 ConfID: 5556230 CauseID: 1457896331 OtherID: 1457896311 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Telmisartan Teva Pharma, telmisartan, Hypertension, Date of authorisation: 03/10/2011, Revision: 8, Status: Authorised DOI: 10.31525/cmr-213770a(Journal) (5556230-N ) DOI: 10.31525/cmr-213fe29(Journal) ========================================================== Created: 2019-11-08 07:47:25.0 ConfID: 5556231 CauseID: 1457896331 OtherID: 1457896312 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Vpriv, velaglucerase alfa, Gaucher Disease, Date of authorisation: 26/08/2010, Revision: 12, Status: Authorised DOI: 10.31525/cmr-213770c(Journal) (5556231-N ) DOI: 10.31525/cmr-213fe2e(Journal) ========================================================== Created: 2019-11-08 07:47:25.0 ConfID: 5556232 CauseID: 1457896331 OtherID: 1457896310 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Roteas, edoxaban, Stroke,Venous Thromboembolism, Date of authorisation: 19/04/2017, Revision: 3, Status: Authorised DOI: 10.31525/cmr-2137704(Journal) (5556232-N ) DOI: 10.31525/cmr-213fe2f(Journal) ========================================================== Created: 2019-11-08 13:29:27.0 ConfID: 5556239 CauseID: 1457908353 OtherID: 1457905139 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves first therapy to treat patients with rare blood disorder DOI: 10.31525/cmr-2144348(Journal) (5556239-N ) DOI: 10.31525/cmr-2144311(Journal) ========================================================== Created: 2019-11-08 15:23:28.0 ConfID: 5556257 CauseID: 1457911067 OtherID: 1457909330 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves luspatercept-aamt for anemia in patients with beta thalassemia DOI: 10.31525/cmr-2145be5(Journal) (5556257-N ) DOI: 10.31525/cmr-2145bad(Journal) ========================================================== Created: 2019-11-08 22:16:19.0 ConfID: 5556261 CauseID: 1457936355 OtherID: 1457896331 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Gilteritinib, Treatment of acute myeloid leukaemia DOI: 10.31525/cmr-213fe28(Journal) (5556261-N ) DOI: 10.31525/cmr-214c889(Journal) ========================================================== Created: 2019-11-08 22:18:38.0 ConfID: 5556262 CauseID: 1457936391 OtherID: 1457896331 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Xospata, gilteritinib, Leukemia, Myeloid, Acute, Date of authorisation: 24/10/2019, Status: Authorised DOI: 10.31525/cmr-213fe2b(Journal) (5556262-N ) DOI: 10.31525/cmr-214c88b(Journal) ========================================================== Created: 2019-11-12 08:15:59.0 ConfID: 5556406 CauseID: 1458079041 OtherID: 1458058000 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Temozolomide Teva, temozolomide, Glioma,Glioblastoma, Date of authorisation: 28/01/2010, Revision: 18, Status: Authorised DOI: 10.31525/cmr-218bd13(Journal) (5556406-N ) DOI: 10.31525/cmr-2194ca0(Journal) ========================================================== Created: 2019-11-13 08:23:53.0 ConfID: 5556772 CauseID: 1458142643 OtherID: 1458116854 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Zaltrap, aflibercept, Colorectal Neoplasms, Date of authorisation: 01/02/2013, Revision: 8, Status: Authorised DOI: 10.31525/cmr-21a0e86(Journal) (5556772-N ) DOI: 10.31525/cmr-21aa048(Journal) ========================================================== Created: 2019-11-14 00:29:08.0 ConfID: 5556859 CauseID: 1458186019 OtherID: 1458142643 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Buccolam, midazolam, Epilepsy, Date of authorisation: 04/09/2011, Revision: 9, Status: Authorised DOI: 10.31525/cmr-21aa047(Journal) (5556859-N ) DOI: 10.31525/cmr-21b600e(Journal) ========================================================== Created: 2019-11-14 15:38:18.0 ConfID: 5557579 CauseID: 1458225308 OtherID: 1458225170 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage DOI: 10.31525/cmr-21c561c(Journal) (5557579-N ) DOI: 10.31525/cmr-21c564f(Journal) ========================================================== Created: 2019-11-14 17:50:21.0 ConfID: 5557595 CauseID: 1458229860 OtherID: 1458229859 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance DOI: 10.31525/cmr-21c764f(Journal) (5557595-N ) DOI: 10.31525/cmr-21c7618(Journal) ========================================================== Created: 2019-11-14 22:21:51.0 ConfID: 5557600 CauseID: 1458247895 OtherID: 1458211941 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: drotrecogin alfa (activated), Treatment of acute respiratory distress syndrome (ARDS) DOI: 10.31525/cmr-21bf3e6(Journal) (5557600-N ) DOI: 10.31525/cmr-21cb18f(Journal) ========================================================== Created: 2019-11-14 22:23:36.0 ConfID: 5557601 CauseID: 1458247908 OtherID: 1458211941 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: eptacog alfa (activated), Treatment of diffuse alveolar haemorrhage DOI: 10.31525/cmr-21bf3e8(Journal) (5557601-N ) DOI: 10.31525/cmr-21cb197(Journal) ========================================================== Created: 2019-11-15 09:16:43.0 ConfID: 5557626 CauseID: 1458269771 OtherID: 1458247895 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Multiple Sclerosis, Date of authorisation: 27/06/2006, Revision: 28, Status: Authorised DOI: 10.31525/cmr-21cb186(Journal) (5557626-N ) DOI: 10.31525/cmr-21d478e(Journal) ========================================================== Created: 2019-11-15 10:56:31.0 ConfID: 5557636 CauseID: 1458273247 OtherID: 1458272101 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA grants accelerated approval to zanubrutinib for mantle cell lymphoma DOI: 10.31525/cmr-21d603c(Journal) (5557636-N ) DOI: 10.31525/cmr-21d601b(Journal) ========================================================== Created: 2019-11-15 15:02:26.0 ConfID: 5557649 CauseID: 1458285725 OtherID: 1458285611 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease DOI: 10.31525/cmr-21da016(Journal) (5557649-N ) DOI: 10.31525/cmr-21da039(Journal) ========================================================== Created: 2019-11-15 15:32:33.0 ConfID: 5557655 CauseID: 1458286886 OtherID: 1458286883 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves crizanlizumab-tmca for sickle cell disease DOI: 10.31525/cmr-21da79c(Journal) (5557655-N ) DOI: 10.31525/cmr-21da779(Journal) ========================================================== Created: 2019-11-15 17:17:34.0 ConfID: 5557659 CauseID: 1458292564 OtherID: 1458292009 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves first contact lens indicated to slow the progression of nearsightedness in children DOI: 10.31525/cmr-21dbdc1(Journal) (5557659-N ) DOI: 10.31525/cmr-21dc015(Journal) ========================================================== Created: 2019-11-15 18:41:34.0 ConfID: 5557662 CauseID: 1458298259 OtherID: 1458298255 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product DOI: 10.31525/cmr-21dd3e7(Journal) (5557662-N ) DOI: 10.31525/cmr-21dd3c5(Journal) ========================================================== Created: 2019-11-15 22:19:16.0 ConfID: 5557663 CauseID: 1458316677 OtherID: 1458269763 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Clopidogrel / Acetylsalicylic acid Mylan,clopidogrel / acetylsalicylic acid DOI: 10.31525/cmr-21d4783(Journal) (5557663-N ) DOI: 10.31525/cmr-21e0302(Journal) ========================================================== Created: 2019-11-15 22:22:16.0 ConfID: 5557664 CauseID: 1458316779 OtherID: 1458269763 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Polivy,polatuzumab vedotin DOI: 10.31525/cmr-21d4782(Journal) (5557664-N ) DOI: 10.31525/cmr-21e0304(Journal) ========================================================== Created: 2019-11-15 22:22:16.0 ConfID: 5557665 CauseID: 1458316779 OtherID: 1458269763 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Kadcyla,trastuzumab emtansine DOI: 10.31525/cmr-21d4785(Journal) (5557665-N ) DOI: 10.31525/cmr-21e0308(Journal) ========================================================== Created: 2019-11-15 22:22:16.0 ConfID: 5557666 CauseID: 1458316779 OtherID: 1458268790 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Isturisa,osilodrostat DOI: 10.31525/cmr-21d477d(Journal) (5557666-N ) DOI: 10.31525/cmr-21e030a(Journal) ========================================================== Created: 2019-11-15 22:22:16.0 ConfID: 5557667 CauseID: 1458316779 OtherID: 1458269763 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Deferasirox Accord,deferasirox DOI: 10.31525/cmr-21d4788(Journal) (5557667-N ) DOI: 10.31525/cmr-21e030d(Journal) ========================================================== Created: 2019-11-15 22:23:00.0 ConfID: 5557668 CauseID: 1458316797 OtherID: 1458269771 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Sunosi,solriamfetol DOI: 10.31525/cmr-21d478a(Journal) (5557668-N ) DOI: 10.31525/cmr-21e030f(Journal) ========================================================== Created: 2019-11-15 22:23:00.0 ConfID: 5557669 CauseID: 1458316797 OtherID: 1458269763 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Tavlesse,fostamatinib DOI: 10.31525/cmr-21d477f(Journal) (5557669-N ) DOI: 10.31525/cmr-21e0311(Journal) ========================================================== Created: 2019-11-15 22:23:00.0 ConfID: 5557670 CauseID: 1458316797 OtherID: 1458269763 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Mayzent,siponimod DOI: 10.31525/cmr-21d4787(Journal) (5557670-N ) DOI: 10.31525/cmr-21e0313(Journal) ========================================================== Created: 2019-11-18 22:20:29.0 ConfID: 5557732 CauseID: 1458499432 OtherID: 1458462303 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos), daunorubicin / cytarabine, Leukemia, Myeloid, Acute, Date of authorisation: 23/08/2018, Revision: 2, Status: Authorised DOI: 10.31525/cmr-2214258(Journal) (5557732-N ) DOI: 10.31525/cmr-221f78e(Journal) ========================================================== Created: 2019-11-19 09:31:25.0 ConfID: 5557788 CauseID: 1458536528 OtherID: 1458499432 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde), irinotecan hydrochloride trihydrate, Pancreatic Neoplasms, Date of authorisation: 14/10/2016, Revision: 4, Status: Authorised DOI: 10.31525/cmr-221f799(Journal) (5557788-N ) DOI: 10.31525/cmr-22295f9(Journal) ========================================================== Created: 2019-11-19 09:46:25.0 ConfID: 5557790 CauseID: 1458537585 OtherID: 1458498889 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Nexavar, sorafenib, Carcinoma, Hepatocellular,Carcinoma, Renal Cell, Date of authorisation: 19/07/2006, Revision: 28, Status: Authorised DOI: 10.31525/cmr-221f788(Journal) (5557790-N ) DOI: 10.31525/cmr-22295ff(Journal) ========================================================== Created: 2019-11-19 09:46:25.0 ConfID: 5557791 CauseID: 1458537585 OtherID: 1458499328 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Myocet liposomal (previously Myocet), doxorubicin, Breast Neoplasms, Date of authorisation: 13/07/2000, Revision: 21, Status: Authorised DOI: 10.31525/cmr-221f789(Journal) (5557791-N ) DOI: 10.31525/cmr-2229602(Journal) ========================================================== Created: 2019-11-19 22:19:17.0 ConfID: 5557835 CauseID: 1458591748 OtherID: 1458537585 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol, Treatment of cystic fibrosis DOI: 10.31525/cmr-22295fd(Journal) (5557835-N ) DOI: 10.31525/cmr-223490b(Journal) ========================================================== Created: 2019-11-19 22:22:17.0 ConfID: 5557837 CauseID: 1458591915 OtherID: 1458537585 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Invanz, ertapenem, Community-Acquired Infections,Streptococcal Infections,Staphylococcal Infections,Gram-Negative Bacterial Infections,Surgical Wound Infection,Pneumonia, Bacterial, Date of authorisation: 18/04/2002, Revision: 22, Status: Authorised DOI: 10.31525/cmr-2229600(Journal) (5557837-N ) DOI: 10.31525/cmr-2234913(Journal) ========================================================== Created: 2019-11-19 22:22:17.0 ConfID: 5557838 CauseID: 1458591915 OtherID: 1458537687 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotropic factor, Treatment of macular telangiectasia type 2 DOI: 10.31525/cmr-2229607(Journal) (5557838-N ) DOI: 10.31525/cmr-2234915(Journal) ========================================================== Created: 2019-11-20 09:49:59.0 ConfID: 5557876 CauseID: 1458633301 OtherID: 1458591748 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Autologous collagen type II-specific regulatory T cells, Treatment of non-infectious uveitis DOI: 10.31525/cmr-223490d(Journal) (5557876-N ) DOI: 10.31525/cmr-223e99f(Journal) ========================================================== Created: 2019-11-20 13:26:00.0 ConfID: 5557897 CauseID: 1458643804 OtherID: 1458642545 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves first treatment for inherited rare disease DOI: 10.31525/cmr-2241547(Journal) (5557897-N ) DOI: 10.31525/cmr-22415e4(Journal) ========================================================== Created: 2019-11-20 14:23:01.0 ConfID: 5557898 CauseID: 1458645919 OtherID: 1458645876 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves givosiran for acute hepatic porphyria DOI: 10.31525/cmr-2242de3(Journal) (5557898-N ) DOI: 10.31525/cmr-2242e81(Journal) ========================================================== Created: 2019-11-20 22:16:19.0 ConfID: 5557928 CauseID: 1458656993 OtherID: 1458632691 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Eculizumab, Treatment myasthenia gravis DOI: 10.31525/cmr-223e998(Journal) (5557928-N ) DOI: 10.31525/cmr-2249a87(Journal) ========================================================== Created: 2019-11-20 22:19:19.0 ConfID: 5557929 CauseID: 1458657107 OtherID: 1458632985 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Halofuginone hydrobromide, Treatment of systemic sclerosis DOI: 10.31525/cmr-223e999(Journal) (5557929-N ) DOI: 10.31525/cmr-2249a89(Journal) ========================================================== Created: 2019-11-20 22:20:47.0 ConfID: 5557930 CauseID: 1458657115 OtherID: 1458632413 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Recombinant human tissue non-specific alkaline phosphatase - Fc - deca-aspartate fusion protein, Treatment of hypophosphatasia DOI: 10.31525/cmr-223e996(Journal) (5557930-N ) DOI: 10.31525/cmr-2249a8b(Journal) ========================================================== Created: 2019-11-20 22:22:03.0 ConfID: 5557931 CauseID: 1458657122 OtherID: 1458633301 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Eculizumab, Treatment of atypical haemolytic uraemic syndrome (aHUS) DOI: 10.31525/cmr-223e9a0(Journal) (5557931-N ) DOI: 10.31525/cmr-2249a99(Journal) ========================================================== Created: 2019-11-20 22:23:23.0 ConfID: 5557932 CauseID: 1458657130 OtherID: 1458633152 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Rixubis, nonacog gamma, Hemophilia B, Date of authorisation: 19/12/2014, Revision: 7, Status: Authorised DOI: 10.31525/cmr-223e99a(Journal) (5557932-N ) DOI: 10.31525/cmr-2249a9d(Journal) ========================================================== Created: 2019-11-20 22:23:23.0 ConfID: 5557933 CauseID: 1458657130 OtherID: 1458633152 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Recombinant human lysosomal acid lipase, Treatment of lysosomal acid lipase deficiency DOI: 10.31525/cmr-223e99b(Journal) (5557933-N ) DOI: 10.31525/cmr-2249a9f(Journal) ========================================================== Created: 2019-11-21 11:50:42.0 ConfID: 5557959 CauseID: 1458692150 OtherID: 1458689886 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemia DOI: 10.31525/cmr-2254e2c(Journal) (5557959-N ) DOI: 10.31525/cmr-2254e72(Journal) ========================================================== Created: 2019-11-21 15:02:44.0 ConfID: 5557961 CauseID: 1458697492 OtherID: 1458697491 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Project Orbis: FDA approves acalabrutinib for CLL and SLL DOI: 10.31525/cmr-2258983(Journal) (5557961-N ) DOI: 10.31525/cmr-225893e(Journal) ========================================================== Created: 2019-11-21 16:56:45.0 ConfID: 5557966 CauseID: 1458700881 OtherID: 1458700880 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves new treatment for adults with partial-onset seizures DOI: 10.31525/cmr-225a494(Journal) (5557966-N ) DOI: 10.31525/cmr-225a44f(Journal) ========================================================== Created: 2019-11-22 22:04:40.0 ConfID: 5558200 CauseID: 1458766631 OtherID: 1458747353 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Trevicta (previously Paliperidone Janssen), paliperidone, Schizophrenia, Date of authorisation: 05/12/2014, Revision: 9, Status: Authorised DOI: 10.31525/cmr-22690d7(Journal) (5558200-N ) DOI: 10.31525/cmr-2273da0(Journal) ========================================================== Created: 2019-11-22 22:04:40.0 ConfID: 5558201 CauseID: 1458766631 OtherID: 1458747353 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Silodyx, silodosin, Prostatic Hyperplasia, Date of authorisation: 29/01/2010, Revision: 13, Status: Authorised DOI: 10.31525/cmr-22690d6(Journal) (5558201-N ) DOI: 10.31525/cmr-2273da2(Journal) ========================================================== Created: 2019-11-22 22:10:40.0 ConfID: 5558202 CauseID: 1458766758 OtherID: 1458747353 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Ivozall, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Date of authorisation: 14/11/2019, Status: Authorised DOI: 10.31525/cmr-22690d5(Journal) (5558202-N ) DOI: 10.31525/cmr-2273da3(Journal) ========================================================== Created: 2019-11-25 15:17:32.0 ConfID: 5558536 CauseID: 1458839181 OtherID: 1458838938 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves novel treatment to target abnormality in sickle cell disease DOI: 10.31525/cmr-22ad1aa(Journal) (5558536-N ) DOI: 10.31525/cmr-22ad310(Journal) ========================================================== Created: 2019-11-25 16:11:32.0 ConfID: 5558538 CauseID: 1458842526 OtherID: 1458842000 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves voxelotor for sickle cell disease DOI: 10.31525/cmr-22addf8(Journal) (5558538-N ) DOI: 10.31525/cmr-22adf5f(Journal) ========================================================== Created: 2019-11-25 17:56:33.0 ConfID: 5558542 CauseID: 1458848540 OtherID: 1458848278 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection DOI: 10.31525/cmr-22af694(Journal) (5558542-N ) DOI: 10.31525/cmr-22af7fa(Journal) ========================================================== Created: 2019-11-25 22:19:09.0 ConfID: 5558554 CauseID: 1458859150 OtherID: 1458825747 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Bortezomib Fresenius Kabi, bortezomib, Multiple Myeloma, Date of authorisation: 14/11/2019, Status: Authorised DOI: 10.31525/cmr-22a8bb6(Journal) (5558554-N ) DOI: 10.31525/cmr-22b320c(Journal) ========================================================== Created: 2019-11-26 10:36:15.0 ConfID: 5558593 CauseID: 1458898039 OtherID: 1458859150 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Votrient, pazopanib, Carcinoma, Renal Cell, Date of authorisation: 14/06/2010, Revision: 22, Status: Authorised DOI: 10.31525/cmr-22b3212(Journal) (5558593-N ) DOI: 10.31525/cmr-22bdf50(Journal) ========================================================== Created: 2019-11-26 10:44:39.0 ConfID: 5558596 CauseID: 1458898308 OtherID: 1458859150 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one, Treatment of follicular lymphoma DOI: 10.31525/cmr-22b3210(Journal) (5558596-N ) DOI: 10.31525/cmr-22bdf53(Journal) ========================================================== Created: 2019-11-26 10:46:42.0 ConfID: 5558597 CauseID: 1458898383 OtherID: 1458859175 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one (duvelisib), Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma DOI: 10.31525/cmr-22b3214(Journal) (5558597-N ) DOI: 10.31525/cmr-22bdf56(Journal) ========================================================== Created: 2019-11-26 10:49:34.0 ConfID: 5558598 CauseID: 1458898458 OtherID: 1457762672 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Evaluation of the Efficacy and Safety of Lebrikizumab in Moderate to Severe Atopic Dermatitis DOI: 10.31525/ct1-nct04146363(Journal) (5558598-N ) DOI: 10.31525/ct1-nct04178967(Journal) ========================================================== Created: 2019-11-26 22:21:46.0 ConfID: 5558616 CauseID: 1458920642 OtherID: 1458898408 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Vectibix, panitumumab, Colorectal Neoplasms, Date of authorisation: 03/12/2007, Revision: 31, Status: Authorised DOI: 10.31525/cmr-22bdf5d(Journal) (5558616-N ) DOI: 10.31525/cmr-22c8395(Journal) ========================================================== Created: 2019-11-26 22:22:54.0 ConfID: 5558617 CauseID: 1458920687 OtherID: 1458898383 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Arsenic trioxide Accord, arsenic trioxide, Leukemia, Promyelocytic, Acute, Date of authorisation: 14/11/2019, Status: Authorised DOI: 10.31525/cmr-22bdf5a(Journal) (5558617-N ) DOI: 10.31525/cmr-22c83a2(Journal) ========================================================== Created: 2019-11-27 10:41:04.0 ConfID: 5558670 CauseID: 1458950866 OtherID: 1458920687 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Deferiprone Lipomed, deferiprone, Iron Overload,beta-Thalassemia, Date of authorisation: 19/09/2018, Revision: 1, Status: Authorised DOI: 10.31525/cmr-22c839d(Journal) (5558670-N ) DOI: 10.31525/cmr-22d32ef(Journal) ========================================================== Created: 2019-11-27 10:49:59.0 ConfID: 5558674 CauseID: 1458951018 OtherID: 1458920642 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Oprymea, pramipexole, Parkinson Disease, Date of authorisation: 12/09/2008, Revision: 19, Status: Authorised DOI: 10.31525/cmr-22c8398(Journal) (5558674-N ) DOI: 10.31525/cmr-22d32fa(Journal) ========================================================== Created: 2019-11-29 22:23:11.0 ConfID: 5559040 CauseID: 1459150125 OtherID: 1459074089 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Senstend, lidocaine / prilocaine, Premature Ejaculation, Date of authorisation: 14/11/2019, Status: Authorised DOI: 10.31525/cmr-22fda2d(Journal) (5559040-N ) DOI: 10.31525/cmr-2307809(Journal) ========================================================== Created: 2019-12-02 22:28:32.0 ConfID: 5559181 CauseID: 1459248780 OtherID: 1459248317 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: S-acetyl-(S)-4''-phosphopantetheine, calcium salt, Treatment of pantothenate-kinase-associated neurodegeneration DOI: 10.31525/cmr-2346c83(Journal) (5559181-N ) DOI: 10.31525/cmr-23470be(Journal) ========================================================== Created: 2019-12-03 22:28:36.0 ConfID: 5559587 CauseID: 1459310109 OtherID: 1459309704 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Rhokiinsa, netarsudil, Glaucoma, Open-Angle,Ocular Hypertension, Date of authorisation: 19/11/2019, Status: Authorised DOI: 10.31525/cmr-235be0f(Journal) (5559587-N ) DOI: 10.31525/cmr-235c45b(Journal) ========================================================== Created: 2019-12-03 22:28:36.0 ConfID: 5559588 CauseID: 1459310109 OtherID: 1459309715 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Synagis, palivizumab, Respiratory Syncytial Virus Infections, Date of authorisation: 13/08/1999, Revision: 40, Status: Authorised DOI: 10.31525/cmr-235be14(Journal) (5559588-N ) DOI: 10.31525/cmr-235c45c(Journal) ========================================================== Created: 2019-12-03 22:28:36.0 ConfID: 5559589 CauseID: 1459310109 OtherID: 1459309704 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: (R)-troloxamide quinone, Treatment of amyotrophic lateral sclerosis DOI: 10.31525/cmr-235be11(Journal) (5559589-N ) DOI: 10.31525/cmr-235c45d(Journal) ========================================================== Created: 2019-12-03 22:28:50.0 ConfID: 5559590 CauseID: 1459310112 OtherID: 1459309704 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Vatiquinone, Treatment of RARS2 syndrome DOI: 10.31525/cmr-235be0c(Journal) (5559590-N ) DOI: 10.31525/cmr-235c465(Journal) ========================================================== Created: 2019-12-03 22:28:50.0 ConfID: 5559591 CauseID: 1459310112 OtherID: 1459309715 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Alpha-tocotrienol quinone, Treatment of Leigh syndrome DOI: 10.31525/cmr-235be17(Journal) (5559591-N ) DOI: 10.31525/cmr-235c467(Journal) ========================================================== Created: 2019-12-04 22:43:23.0 ConfID: 5559711 CauseID: 1459361952 OtherID: 1459361039 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: 4-hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl, Treatment of familial cerebral cavernous malformations DOI: 10.31525/cmr-2370f81(Journal) (5559711-N ) DOI: 10.31525/cmr-23717fa(Journal) ========================================================== Created: 2019-12-04 22:55:23.0 ConfID: 5559712 CauseID: 1459362141 OtherID: 1459361561 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Teysuno, tegafur / gimeracil / oteracil, Stomach Neoplasms, Date of authorisation: 14/03/2011, Revision: 16, Status: Authorised DOI: 10.31525/cmr-2370f89(Journal) (5559712-N ) DOI: 10.31525/cmr-23717fb(Journal) ========================================================== Created: 2019-12-04 23:03:38.0 ConfID: 5559715 CauseID: 1459362312 OtherID: 1459361561 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: Ivosidenib, Treatment of acute myeloid leukaemia DOI: 10.31525/cmr-2370f8b(Journal) (5559715-N ) DOI: 10.31525/cmr-23717fe(Journal) ========================================================== Created: 2019-12-05 12:01:47.0 ConfID: 5559958 CauseID: 1459397159 OtherID: 1459397158 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria DOI: 10.31525/cmr-237d305(Journal) (5559958-N ) DOI: 10.31525/cmr-237d462(Journal) ========================================================== Created: 2019-12-05 14:07:48.0 ConfID: 5559959 CauseID: 1459401563 OtherID: 1459401532 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves atezolizumab with nab-paclitaxel and carboplatin for metastatic NSCLC without EGFR/ALK aberrations DOI: 10.31525/cmr-237f08f(Journal) (5559959-N ) DOI: 10.31525/cmr-237f1eb(Journal) ========================================================== Created: 2019-12-05 15:28:05.0 ConfID: 5559960 CauseID: 1459402529 OtherID: 1459402458 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves first generics of Gilenya DOI: 10.31525/cmr-2380324(Journal) (5559960-N ) DOI: 10.31525/cmr-238043d(Journal) ========================================================== Created: 2019-12-09 23:26:42.0 ConfID: 5566620 CauseID: 1459625761 OtherID: 1459620974 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron), dinutuximab beta, Neuroblastoma, Date of authorisation: 08/05/2017, Revision: 7, Status: Authorised DOI: 10.31525/cmr-23da701(Journal) (5566620-N ) DOI: 10.31525/cmr-23dba17(Journal) ========================================================== Created: 2019-12-10 23:47:48.0 ConfID: 5566715 CauseID: 1459698211 OtherID: 1459693785 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Qtrilmet, metformin hydrochloride / saxagliptin / dapagliflozin, Diabetes Mellitus, Type 2, Date of authorisation: 11/11/2019, Status: Authorised DOI: 10.31525/cmr-23ef88d(Journal) (5566715-N ) DOI: 10.31525/cmr-23f0dba(Journal) ========================================================== Created: 2019-12-12 11:56:51.0 ConfID: 5566903 CauseID: 1459849100 OtherID: 1459848898 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA authorizes first test to aid in newborn screening for Duchenne Muscular Dystrophy DOI: 10.31525/cmr-2410c70(Journal) (5566903-N ) DOI: 10.31525/cmr-2410d98(Journal) ========================================================== Created: 2019-12-12 18:05:54.0 ConfID: 5566915 CauseID: 1459866757 OtherID: 1459866619 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation DOI: 10.31525/cmr-2416295(Journal) (5566915-N ) DOI: 10.31525/cmr-24163ba(Journal) ========================================================== Created: 2019-12-12 23:56:56.0 ConfID: 5566922 CauseID: 1459876121 OtherID: 1459873651 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Ervebo, Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live), Hemorrhagic Fever, Ebola, Date of authorisation: 11/11/2019, Status: Authorised DOI: 10.31525/cmr-2419b89(Journal) (5566922-N ) DOI: 10.31525/cmr-241b4f1(Journal) ========================================================== Created: 2019-12-13 11:56:59.0 ConfID: 5566984 CauseID: 1459907409 OtherID: 1459907114 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system DOI: 10.31525/cmr-2425df1(Journal) (5566984-N ) DOI: 10.31525/cmr-2425ec2(Journal) ========================================================== Created: 2019-12-13 16:36:12.0 ConfID: 5566987 CauseID: 1459913609 OtherID: 1459913368 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups DOI: 10.31525/cmr-2429ebe(Journal) (5566987-N ) DOI: 10.31525/cmr-242a064(Journal) ========================================================== Created: 2019-12-14 00:23:53.0 ConfID: 5566997 CauseID: 1459927249 OtherID: 1456430431, 1459927249 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Darzalex,daratumumab DOI: 10.31525/cmr-1f91907(Journal) (5566997-N ) DOI: 10.31525/cmr-243089c(Journal) ========================================================== Created: 2019-12-14 00:00:04.0 ConfID: 5567011 CauseID: 1459926806 OtherID: 1459924831 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Vyndaqel,tafamidis DOI: 10.31525/cmr-242ed15(Journal) (5567011-N ) DOI: 10.31525/cmr-243088f(Journal) ========================================================== Created: 2019-12-14 00:09:04.0 ConfID: 5567012 CauseID: 1459926939 OtherID: 1459924742 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Sirturo,bedaquiline DOI: 10.31525/cmr-242ed05(Journal) (5567012-N ) DOI: 10.31525/cmr-2430890(Journal) ========================================================== Created: 2019-12-14 00:21:01.0 ConfID: 5567013 CauseID: 1459927239 OtherID: 1459924805 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Amsparity,adalimumab DOI: 10.31525/cmr-242ed11(Journal) (5567013-N ) DOI: 10.31525/cmr-2430891(Journal) ========================================================== Created: 2019-12-14 00:21:01.0 ConfID: 5567014 CauseID: 1459927239 OtherID: 1459924742 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Erleada,apalutamide DOI: 10.31525/cmr-242ed06(Journal) (5567014-N ) DOI: 10.31525/cmr-2430892(Journal) ========================================================== Created: 2019-12-14 00:21:01.0 ConfID: 5567015 CauseID: 1459927239 OtherID: 1459924850 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Cyramza,ramucirumab DOI: 10.31525/cmr-242ed18(Journal) (5567015-N ) DOI: 10.31525/cmr-2430893(Journal) ========================================================== Created: 2019-12-14 00:21:01.0 ConfID: 5567016 CauseID: 1459927239 OtherID: 1459924805 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Recarbrio,imipenem / cilastatin / relebactam DOI: 10.31525/cmr-242ed0d(Journal) (5567016-N ) DOI: 10.31525/cmr-2430894(Journal) ========================================================== Created: 2019-12-14 00:21:01.0 ConfID: 5567017 CauseID: 1459927239 OtherID: 1459924805 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Dexmedetomidine Accord,dexmedetomidine DOI: 10.31525/cmr-242ed0a(Journal) (5567017-N ) DOI: 10.31525/cmr-2430895(Journal) ========================================================== Created: 2019-12-14 00:22:19.0 ConfID: 5567018 CauseID: 1459927246 OtherID: 1459924376 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Akynzeo,netupitant / palonosetron DOI: 10.31525/cmr-242ed03(Journal) (5567018-N ) DOI: 10.31525/cmr-2430897(Journal) ========================================================== Created: 2019-12-14 00:22:19.0 ConfID: 5567019 CauseID: 1459927246 OtherID: 1459924805 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Azacitidine Accord,azacitidine DOI: 10.31525/cmr-242ed0f(Journal) (5567019-N ) DOI: 10.31525/cmr-2430898(Journal) ========================================================== Created: 2019-12-14 00:22:19.0 ConfID: 5567020 CauseID: 1459927246 OtherID: 1459924015 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Dificlir,fidaxomicin DOI: 10.31525/cmr-242ed02(Journal) (5567020-N ) DOI: 10.31525/cmr-2430899(Journal) ========================================================== Created: 2019-12-14 00:22:19.0 ConfID: 5567021 CauseID: 1459927246 OtherID: 1459924742 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Summary of opinion: Beovu,brolucizumab DOI: 10.31525/cmr-242ed08(Journal) (5567021-N ) DOI: 10.31525/cmr-243089a(Journal) ========================================================== Created: 2019-12-17 00:31:26.0 ConfID: 5567588 CauseID: 1460043170 OtherID: 1460040889 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Fampyra, fampridine, Multiple Sclerosis, Date of authorisation: 20/07/2011, Revision: 13, Status: Authorised DOI: 10.31525/cmr-246e186(Journal) (5567588-N ) DOI: 10.31525/cmr-247036b(Journal) ========================================================== Created: 2019-12-17 08:19:16.0 ConfID: 5567685 CauseID: 1460075371 OtherID: 1460075125 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves enzalutamide for metastatic castration-sensitive prostate cancer DOI: 10.31525/cmr-2477043(Journal) (5567685-N ) DOI: 10.31525/cmr-247722a(Journal) ========================================================== Created: 2019-12-17 10:37:17.0 ConfID: 5567693 CauseID: 1460082271 OtherID: 1460081953 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA permits sale of two new reduced nicotine cigarettes through premarket tobacco product application pathway DOI: 10.31525/cmr-2479042(Journal) (5567693-N ) DOI: 10.31525/cmr-2479228(Journal) ========================================================== Created: 2019-12-18 17:37:57.0 ConfID: 5567795 CauseID: 1460146184 OtherID: 1460146149 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves new type of therapy to treat advanced urothelial cancer DOI: 10.31525/cmr-24945c5(Journal) (5567795-N ) DOI: 10.31525/cmr-24946a5(Journal) ========================================================== Created: 2019-12-19 00:51:31.0 ConfID: 5567804 CauseID: 1460162542 OtherID: 1460158364 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Bretaris Genuair, aclidinium bromide, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 20/07/2012, Revision: 16, Status: Authorised DOI: 10.31525/cmr-2498481(Journal) (5567804-N ) DOI: 10.31525/cmr-249aaaa(Journal) ========================================================== Created: 2019-12-19 00:51:31.0 ConfID: 5567805 CauseID: 1460162542 OtherID: 1460158388 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt (niraparib), Treatment of ovarian cancer DOI: 10.31525/cmr-2498486(Journal) (5567805-N ) DOI: 10.31525/cmr-249aaab(Journal) ========================================================== Created: 2019-12-19 00:59:48.0 ConfID: 5567806 CauseID: 1460162900 OtherID: 1460158388 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Eklira Genuair, aclidinium bromide, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 20/07/2012, Revision: 16, Status: Authorised DOI: 10.31525/cmr-2498482(Journal) (5567806-N ) DOI: 10.31525/cmr-249aaae(Journal) ========================================================== Created: 2019-12-19 10:54:04.0 ConfID: 5567830 CauseID: 1460195032 OtherID: 1460194803 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA grants accelerated approval to enfortumab vedotin-ejfv for metastatic urothelial cancer DOI: 10.31525/cmr-24a3827(Journal) (5567830-N ) DOI: 10.31525/cmr-24a3968(Journal) ========================================================== Created: 2019-12-19 19:25:23.0 ConfID: 5567933 CauseID: 1460215883 OtherID: 1460215718 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response DOI: 10.31525/cmr-24aaf8a(Journal) (5567933-N ) DOI: 10.31525/cmr-24ab0c1(Journal) ========================================================== Created: 2019-12-20 00:54:10.0 ConfID: 5567939 CauseID: 1460224232 OtherID: 1460220854 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Emend, aprepitant, Vomiting,Postoperative Nausea and Vomiting,Cancer, Date of authorisation: 11/11/2003, Revision: 25, Status: Authorised DOI: 10.31525/cmr-24ad82a(Journal) (5567939-N ) DOI: 10.31525/cmr-24afe47(Journal) ========================================================== Created: 2019-12-20 01:15:10.0 ConfID: 5567940 CauseID: 1460224599 OtherID: 1460220854 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Comtan, entacapone, Parkinson Disease, Date of authorisation: 22/09/1998, Revision: 24, Status: Authorised DOI: 10.31525/cmr-24ad82c(Journal) (5567940-N ) DOI: 10.31525/cmr-24afe4c(Journal) ========================================================== Created: 2019-12-20 01:15:10.0 ConfID: 5567941 CauseID: 1460224599 OtherID: 1460220839 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Spravato, esketamine, Depressive Disorder, Date of authorisation: 18/12/2019, Status: Authorised DOI: 10.31525/cmr-24ad822(Journal) (5567941-N ) DOI: 10.31525/cmr-24afe50(Journal) ========================================================== Created: 2019-12-20 13:56:07.0 ConfID: 5568023 CauseID: 1460263177 OtherID: 1460262928 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies DOI: 10.31525/cmr-24bb467(Journal) (5568023-N ) DOI: 10.31525/cmr-24bb59f(Journal) ========================================================== Created: 2019-12-20 16:09:39.0 ConfID: 5568056 CauseID: 1460265706 OtherID: 1460265604 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive breast cancer DOI: 10.31525/cmr-24bd324(Journal) (5568056-N ) DOI: 10.31525/cmr-24bd465(Journal) ========================================================== Created: 2019-12-21 01:09:42.0 ConfID: 5568073 CauseID: 1460278841 OtherID: 1460274421 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Skin Diseases, Bacterial, Date of authorisation: 16/12/2019, Status: Authorised DOI: 10.31525/cmr-24c2bc7(Journal) (5568073-N ) DOI: 10.31525/cmr-24c51e6(Journal) ========================================================== Created: 2019-12-21 01:11:42.0 ConfID: 5568074 CauseID: 1460278872 OtherID: 1460274435 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Kolbam , cholic acid, Metabolism, Inborn Errors, Date of authorisation: 20/11/2015, Revision: 13, Status: Authorised DOI: 10.31525/cmr-24c2bce(Journal) (5568074-N ) DOI: 10.31525/cmr-24c51ea(Journal) ========================================================== Created: 2019-12-21 01:13:13.0 ConfID: 5568075 CauseID: 1460278897 OtherID: 1460274421 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Human medicines European public assessment report (EPAR): Pegfilgrastim Mundipharma, pegfilgrastim, Neutropenia, Date of authorisation: 19/12/2019, Status: Authorised DOI: 10.31525/cmr-24c2bcd(Journal) (5568075-N ) DOI: 10.31525/cmr-24c51f1(Journal) ========================================================== Created: 2019-12-23 14:39:28.0 ConfID: 5568182 CauseID: 1460352631 OtherID: 1460352459 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves new treatment for adults with migraine DOI: 10.31525/cmr-24fb2ef(Journal) (5568182-N ) DOI: 10.31525/cmr-24fb42d(Journal) ========================================================== Created: 2019-12-23 15:06:10.0 ConfID: 5568183 CauseID: 1460353353 OtherID: 1460353179 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves first generics of Eliquis DOI: 10.31525/cmr-24fb91b(Journal) (5568183-N ) DOI: 10.31525/cmr-24fba51(Journal) ========================================================== Created: 2019-12-30 15:54:19.0 ConfID: 5568501 CauseID: 1460588031 OtherID: 1460588019 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves olaparib for gBRCAm metastatic pancreatic adenocarcinoma DOI: 10.31525/cmr-258fffc(Journal) (5568501-N ) DOI: 10.31525/cmr-2590075(Journal) ========================================================== Created: 2020-01-02 22:43:48.0 ConfID: 5569274 CauseID: 1460750521 OtherID: 1460750508 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris DOI: 10.31525/ct1-nct04214652(Journal) (5569274-N ) DOI: 10.31525/ct1-nct04214639(Journal) ========================================================== Created: 2020-01-06 22:57:10.0 ConfID: 5569612 CauseID: 1460968966 OtherID: 1460968894 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,Orphan designation: Three human monoclonal antibodies against the EBOV glycoprotein, Treatment of Ebola virus disease DOI: 10.31525/cmr-2629dbe(Journal) (5569612-N ) DOI: 10.31525/cmr-2629dbf(Journal) ========================================================== Created: 2020-01-06 22:56:37.0 ConfID: 5569613 CauseID: 1460968933 OtherID: 1460968908 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,Orphan designation: human monoclonal antibody against activin A, Treatment of fibrodysplasia ossificans progressiva DOI: 10.31525/cmr-2629db8(Journal) (5569613-N ) DOI: 10.31525/cmr-2629dc2(Journal) ========================================================== Created: 2020-01-06 22:56:11.0 ConfID: 5569614 CauseID: 1460968908 OtherID: 1460968933 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,Orphan designation: Tipifarnib, Treatment of acute myeloid leukaemia DOI: 10.31525/cmr-2629dc1(Journal) (5569614-N ) DOI: 10.31525/cmr-2629dbc(Journal) ========================================================== Created: 2020-01-06 22:56:37.0 ConfID: 5569615 CauseID: 1460968933 OtherID: 1460968908 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,Human medicines European public assessment report (EPAR): Vanflyta, quizartinib, Leukemia, Myeloid, Acute, Date of refusal: 19/12/2019, Status: Refused DOI: 10.31525/cmr-2629dbb(Journal) (5569615-N ) DOI: 10.31525/cmr-2629dc4(Journal) ========================================================== Created: 2020-01-07 23:08:06.0 ConfID: 5569745 CauseID: 1461048161 OtherID: 1461048072 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,Human medicines European public assessment report (EPAR): TachoSil, human fibrinogen / human thrombin, Hemostasis, Surgical, Date of authorisation: 08/06/2004, Revision: 23, Status: Authorised DOI: 10.31525/cmr-263f161(Journal) (5569745-N ) DOI: 10.31525/cmr-263f154(Journal) ========================================================== Created: 2020-01-08 14:20:36.0 ConfID: 5569786 CauseID: 1461120792 OtherID: 1461120022 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer DOI: 10.31525/cmr-264c772(Journal) (5569786-N ) DOI: 10.31525/cmr-264c778(Journal) ========================================================== Created: 2020-01-09 15:41:47.0 ConfID: 5569898 CauseID: 1461220890 OtherID: 1461220889 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors DOI: 10.31525/cmr-2662c50(Journal) (5569898-N ) DOI: 10.31525/cmr-2662c49(Journal) ========================================================== Created: 2020-01-09 17:05:47.0 ConfID: 5569904 CauseID: 1461225413 OtherID: 1461225412 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,FDA approves avapritinib for gastrointestinal stromal tumor with a rare mutation DOI: 10.31525/cmr-2664001(Journal) (5569904-N ) DOI: 10.31525/cmr-2663ff9(Journal) ========================================================== Created: 2020-01-09 23:23:50.0 ConfID: 5569914 CauseID: 1461243563 OtherID: 1461243559 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,Human medicines European public assessment report (EPAR): Nityr, nitisinone, Tyrosinemias, Date of authorisation: 26/07/2018, Revision: 1, Status: Authorised DOI: 10.31525/cmr-2669898(Journal) (5569914-N ) DOI: 10.31525/cmr-2669890(Journal) ========================================================== Created: 2020-01-09 23:26:19.0 ConfID: 5569915 CauseID: 1461243673 OtherID: 1461243559 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,Human medicines European public assessment report (EPAR): Seebri Breezhaler, glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, Date of authorisation: 28/09/2012, Revision: 9, Status: Authorised DOI: 10.31525/cmr-266989a(Journal) (5569915-N ) DOI: 10.31525/cmr-2669896(Journal) ========================================================== Created: 2020-01-10 23:50:03.0 ConfID: 5570376 CauseID: 1461338135 OtherID: 1461337776 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,Human medicines European public assessment report (EPAR): Xofigo, radium Ra223 dichloride, Prostatic Neoplasms, Date of authorisation: 13/11/2013, Revision: 10, Status: Authorised DOI: 10.31525/cmr-267ec37(Journal) (5570376-N ) DOI: 10.31525/cmr-267ec31(Journal) ========================================================== Created: 2020-01-10 23:59:03.0 ConfID: 5570377 CauseID: 1461338397 OtherID: 1461338299 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,Human medicines European public assessment report (EPAR): Firmagon, degarelix, Prostatic Neoplasms, Date of authorisation: 17/02/2009, Revision: 14, Status: Authorised DOI: 10.31525/cmr-267ec3d(Journal) (5570377-N ) DOI: 10.31525/cmr-267ec3a(Journal) ========================================================== Created: 2020-02-17 22:15:30.0 ConfID: 5577480 CauseID: 1463558256 OtherID: 1463558240 JT: Case Medical Research MD: Case Medical Research,null,null,null,2020,Pattern Recognition Prosthetic Control DOI: 10.31525/ct1-nct04272489(Journal) (5577480-N ) DOI: 10.31525/ct1-nct04272593(Journal) ========================================================== Created: 2020-02-20 22:44:00.0 ConfID: 5577894 CauseID: 1463751353 OtherID: 1445305814 JT: Case Medical Research MD: Case Medical Research,null,null,null,2019,FDA approves new oral treatment for multiple sclerosis DOI: 10.31525/fda2-ucm634837.htm(Journal) (5577894-N ) DOI: 10.31525/cmr-29deadf(Journal)